Hanwha Donepezil Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

○ Adults : Administer donepezil hydrochloride 5 mg once daily at bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, taking this medicine in the morning may be considered. Because donepezil concentrations reach steady state 15 days after administration and the frequency of adverse reactions may be affected by the rate of dose escalation, administer the 5 mg dose for 4～6 weeks. After assessing the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg daily, administer with attention to gastrointestinal adverse reactions. If administration of this medicine is discontinued, its effects gradually decrease, and no rebound effect occurs after abrupt discontinuation. ○ Female patients aged 85 years and older with low body weight : Adverse reactions occur more frequently, so careful monitoring is required. Elderly women with low body weight should not receive more than 5 mg daily.

Child dose

○ Children : There is no experience with use in children.

This product contains the active ingredient Donepezil Hydrochloride and is primarily used to relieve symptoms of Alzheimer's type dementia. This medication should not be given to certain patients. For example, individuals who are allergic to this medication or its components, pregnant or potentially pregnant women, nursing mothers, and individuals with lactose intolerance or hereditary sugar absorption disorders should not take this medication. Patients with heart disease or conduction abnormalities should use this medication with caution because it may slow the heart rate or induce arrhythmias. Patients with a history of gastric ulcers or peptic ulcers or who are taking non-steroidal anti-inflammatory drugs should also be cautious. This medication may stimulate gastric acid secretion and increase gastrointestinal motility, worsening ulcer symptoms. Patients with asthma or obstructive pulmonary disease should be careful as their symptoms may worsen with this medication. Patients with extrapyramidal disorders such as Parkinson's disease may experience worsening symptoms when taking this medication. This medication contains a dye called Yellow No. 5, and those with allergic reactions to it should use it with caution. This medication may lead to various adverse reactions. Cardiac-related adverse events may include syncope, bradycardia, heart block, and myocardial infarction, whereas gastrointestinal side effects may include gastrointestinal bleeding, ulcers, nausea, vomiting, and diarrhea. Serious side effects related to liver dysfunction, epileptic seizures, muscle pain, rhabdomyolysis, shortness of breath, acute pancreatitis, acute renal failure, and sudden death have also been reported. Psychiatric issues may include hallucinations, agitation, anxiety, insomnia, confusion, depression, and aggressive behavior. Due to the risk of inducing cardiac arrhythmias, patients with a history of heart disease may require regular electrocardiogram monitoring. Additionally, this medication may affect the ability to drive or operate machinery, so caution is advised. Pregnant or nursing women are advised not to take this medication unless absolutely necessary and should consult a specialist. The safety of this medication in children has not yet been established, so it should not be used in pediatric patients. This medication is primarily metabolized in the liver and may interact with other drugs. Special caution is needed when used with certain antibiotics, antidepressants, antiarrhythmics, and antipsychotic medications, as some drugs may enhance or reduce the effects of this medication. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, and immediate medical attention should be sought. This medication should be kept out of the reach of children and should not be transferred to other containers.

• Syncope
• bradycardia
• heart block
• prolonged QT interval
• myocardial infarction
• heart failure
• peptic ulcer
• perforated duodenal perforation
• gastrointestinal bleeding
• hepatitis

This medication should be stored in a tightly sealed container to prevent exposure to air, and it is advisable to keep it at room temperature between 1 to 30 degrees Celsius. This is to maintain the efficacy of the medication and prevent degradation.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle